Description

Topiroxostat Impurity 23 is a designated impurity reference standard used in the pharmaceutical development and quality control of Topiroxostat, a xanthine oxidase inhibitor. This high-purity compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Topiroxostat drug substance and drug products.
• Impurity Profiling & Identification: Used in HPLC, UPLC, and LC-MS methods to identify, characterize, and quantify Impurity 23 in Topiroxostat batches.
• Method Development & Validation (HPLC/LC-MS): Essential for developing and validating stability-indicating analytical methods as per ICH Q2(R1) guidelines.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (forced degradation studies) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Quality Control & Batch Release: A critical tool for in-process testing and final release of Topiroxostat API to ensure it meets stringent pharmacopeial limits for related substances.

Basic Information

Product Name	Topiroxostat Impurity 23
CAS No.	2044706-78-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Topiroxostat Related Compound 23; Topiroxostat Impurity C; 2-[(3,5-Dicyano-4-isobutoxy-6-methylpyridin-2-yl)thio]acetic Acid (putative structure based on naming convention); FX-006 Impurity 23; UR-1102 Impurity; Febuxostat Analog Impurity; Xanthine Oxidase Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Topiroxostat Impurity 23 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is supplied with each shipment, detailing batch-specific results. Production can be aligned with ICH Q3A/B and current pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is typically hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.